Safety of ashitaba sap as a Novel food pursuant to Regulation (EU) 2015/2283

Safety of ashitaba sap as a Novel food pursuant to Regulation (EU) 2015/2283

Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on ashitaba sap as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Ashitaba sap is collected from harvested stems of Angelica keiskei...

Full description

Saved in:
Bibliographic Details
Main Authors: EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch‐Ernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, Margarita Aguilera‐Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Miguel Prieto Maradona, Monika Neuhäuser‐Berthold, Morten Poulsen, Josef Rudolf Schlatter, Alexandros Siskos, Henk vanLoveren, Maria Glymenaki, Eirini Kouloura, Helle Katrine Knutsen
Format: Article
Language:English
Published: Wiley 2024-03-01
Series:EFSA Journal
Subjects:
Angelica keiskei
ashitaba
food supplement
novel foods
safety
Online Access:https://doi.org/10.2903/j.efsa.2024.8645
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on ashitaba sap as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Ashitaba sap is collected from harvested stems of Angelica keiskei plants. The principal constituents of the sap with regard to the safety assessment are chalcones (1%–2.25%) and furanocoumarins (< 0.01%). The applicant proposed to use the NF in food supplements at a maximum dose of 780 mg per day. The target population is adults excluding pregnant and lactating women. Taking into consideration the composition of the NF and the proposed uses, the composition of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90‐day oral toxicity study performed with the product as intended to be placed on the market (30% ashitaba sap powder and 70% cyclodextrins), the Panel establishes a safe dose of 0.5 mg/kg body weight (bw) per day for the product as it is intended to be placed on the market. For the target population, i.e. adults, this safe dose corresponds to 35 mg per day of the product as it is intended to be placed on the market and 137 mg per day of the NF, which is lower than the use level proposed by the applicant. The Panel concludes that the NF is safe for the target population at intake levels up to 137 mg per day.
ISSN:1831-4732

Similar Items